A condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram.

Must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

History of significant sensitivity or allergy to any drug.

Use of known inhibitors or inducers of CYP3A within 30 days prior to the first dose of study drug and through the end of the study.

Requirement for, or use of within the 2-week period prior to study drug administration, any over-the-counter or prescription medication, vitamins, minerals or herbal supplements on a regular basis.

Receipt of any depot drug by injection within 30 days prior to study drug administration.

Positive screen for drugs of abuse or alcohol, or recent (6-month) history of drug or alcohol abuse.

Use of tobacco or other nicotine-containing products within the six-month period preceding study drug administration.

Donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first dose of study drug.

Receipt of an investigational product within a time period equal to 10 half-lives, if known, or a minimum of 6 weeks prior to study drug administration.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050127